DEC3-VEN vs. Venetoclax-Based vs. DA Regimens in Newly Diagnosed AML

Summary

Protocol Title: A Prospective, Randomized Controlled Study of Venetoclax Plus 3-Day Decitabine (DEC3-VEN) Versus Venetoclax Plus "2+6" DA Versus "3+7" DA Regimen in Adult Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

Objective: This is a prospective, open-label, randomized, multicenter, phase II trial designed to compare the efficacy and safety of three induction regimens-Venetoclax plus 3-day Decitabine (DEC3-VEN), Venetoclax plus "2+6" DA, and standard "3+7" DA-in adult patients with newly diagnosed, intensifiable AML.

Study Design: The study employs a prospective, randomized, controlled, multicenter design. A total of 291 eligible patients will be enrolled across approximately 10 centers in China and randomized in a 2:2:1 ratio to the three treatment arms.

Key Eligibility Criteria:

Inclusion: Aged 16-65 with newly diagnosed non-APL AML (excluding favorable CBF-AML), eligible for intensive chemotherapy, ECOG ≤2, and adequate organ function.

Exclusion: Prior AML treatment, secondary AML, active severe infection, significant cardiac comorbidity, or known hypersensitivity to the study drugs.

Interventions:

Induction:

Arm A (VEN+"2+6"DA): Venetoclax (D1-8), Daunorubicin (D2-3), Cytarabine (D2-7).

Arm B (DEC3-VEN): Venetoclax (D1-14), Decitabine (D4-6). FLT3/ITD+ patients add Sorafenib or Gilteritinib (D8-14).

Arm C ("3+7"DA): Daunorubicin (D1-3), Cytarabine (D1-7).

Consolidation (2 cycles):

Arms A/B: Venetoclax + Intermediate-Dose Cytarabine.

Arm C: High-Dose Cytarabine.

Consolidation (Subsequent cycles):

All arms receive multiple cycles of DA or HA regimens.

Maintenance (6-8 cycles):

Arms A/B: Venetoclax + Azacitidine.

Arm C: Azacitidine.

Main Outcome Measures:

Primary Endpoint: Composite Complete Remission Rate (CR + CRi) after induction.

Secondary Endpoints: Overall Survival (OS), CR rate, MRD-negative rate, Relapse-Free Survival (RFS), Event-Free Survival (EFS), and safety.

Keywords: Acute Myeloid Leukemia, Venetoclax, Decitabine, Consolidation Therapy, Maintenance Therapy, Randomized Controlled Trial.

Conditions

• AML (Acute Myeloid Leukemia)

Interventions

PROCEDURE

Arm A (VEN+"2+6"DA)

Venetoclax (Days 1-8), Daunorubicin (Days 2-3), Cytarabine (Days 2-7)

PROCEDURE

Arm B (DEC3-VEN)

Venetoclax (Days 1-14), Decitabine (Days 4-6). FLT3/ITD-positive patients receive additional Sorafenib or Gilteritinib (Days 8-14).

PROCEDURE

Arm C ("3+7"DA)

Daunorubicin (Days 1-3), Cytarabine (Days 1-7)

Sponsors & Collaborators

• State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chines

  collaborator UNKNOWN

• Department of Hematology, Oncology Center, Tianjin Union Medical Center of Nankai University

  collaborator UNKNOWN

• Department of Hematology, Handan Central Hospital

  collaborator UNKNOWN

• Department of Hematology, The Affiliated Tai'an City Central Hospital of Qingdao University

  collaborator UNKNOWN

• Department of Hematology, The First Affiliated Hospital of Guangxi Medical University

  collaborator UNKNOWN

• Department of Hematology, The Second Xiangya Hospital, Central South University

  collaborator UNKNOWN

• Department of Hematology, Guizhou Provincial People's Hospital

  collaborator UNKNOWN

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• Affiliated Hospital of Qinghai University

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-01

Primary Completion

2026-12-01

Completion

2027-12-01

Countries

• China

Study Locations